A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Samyang Biopharmaceuticals Corporation.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Samyang Biopharmaceuticals Corporation
Information provided by:
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01276548
First received: January 12, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Drug: Genexol®-PM plus Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Samyang Biopharmaceuticals Corporation:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who aged 18 years or older
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial
- Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required.
Exclusion Criteria:
- Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication.
- Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial.
- Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276548
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Songpa-gu, Pungnap-2 Dong, Korea, Republic of, 138-736 | |
| Contact: Eun Ja Kim 82-2-3010-3629 | |
| Principal Investigator: Yong-Man Kim, M.D. Ph.D. | |
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01276548 History of Changes |
| Other Study ID Numbers: | GPMOC202 |
| Study First Received: | January 12, 2011 |
| Last Updated: | January 12, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Nonoxynol |
Octoxynol Carboplatin Spermatocidal Agents Antispermatogenic Agents Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Male Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013